# K964791: B2 Microglobulin Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: May 29, 1997 after 181 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott IMX beta-2-Microglobulin Assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure the concentration of 32-microglobulin in human serum and urine using the Technicon Immuno 1® system. B2-Microglobulin assay values obtained should be used in conjunction with information available from clinical and other diagnostic procedures in the management of patients with renal dysfunction and rheumatoid arthritis. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K964791
Methodology: https://510kreport.com/methodology